Deeming Regulations have been released!!!!

[classwife]

And...on the news this morning... (a bit of an eye roll from me...)

Column: Don’t let FDA take the

Column: Don’t let FDA take the "cigar" out of our Cigar City

From that article :
"This one-size-fits-all policy does not make sense for our small, boutique industry. The FDA has subjected us to the same warning label, health testing, product standards and other requirements created for the $100 billion cigarette industry. Recent estimates predict that it will cost $30 million just for our Tampa factory."

And :
"By its own admission, the FDA concluded that up to half of all cigar companies would be forced to close because of the enormous cost of compliance. If FDA regulations are fully implemented, our Ybor City factory would be one of the casualties — meaning Tampa would no longer be the Cigar City.

All is not lost, but we do need your help. At the urging of Rep. Kathy Castor, Sens. Bill Nelson and Marco Rubio and other members of Congress, the Trump administration is reconsidering the regulation of premium cigars. As part of this process, the FDA has invited the public to comment on premium cigars through June 25. (Visit SaveCigarCity.com to see how to help.)"

And :
"Recent studies written or funded by the FDA have shown that children do not smoke premium cigars, that premium cigars are smoked infrequently, and that premium cigars do not substantially increase the rate of mortality. Because premium cigars are fundamentally different from other tobacco products, they need to be treated differently too."



Because e-cigarettes are fundamentally different from other tobacco products, they need to be treated differently too.

 

[Myk]

And...on the news this morning... (a bit of an eye roll from me...)

Column: Don’t let FDA take the

Column: Don’t let FDA take the "cigar" out of our Cigar City

From that article :
"This one-size-fits-all policy does not make sense for our small, boutique industry. The FDA has subjected us to the same warning label, health testing, product standards and other requirements created for the $100 billion cigarette industry. Recent estimates predict that it will cost $30 million just for our Tampa factory."

And :
"By its own admission, the FDA concluded that up to half of all cigar companies would be forced to close because of the enormous cost of compliance. If FDA regulations are fully implemented, our Ybor City factory would be one of the casualties — meaning Tampa would no longer be the Cigar City.

All is not lost, but we do need your help. At the urging of Rep. Kathy Castor, Sens. Bill Nelson and Marco Rubio and other members of Congress, the Trump administration is reconsidering the regulation of premium cigars. As part of this process, the FDA has invited the public to comment on premium cigars through June 25. (Visit SaveCigarCity.com to see how to help.)"

And :
"Recent studies written or funded by the FDA have shown that children do not smoke premium cigars, that premium cigars are smoked infrequently, and that premium cigars do not substantially increase the rate of mortality. Because premium cigars are fundamentally different from other tobacco products, they need to be treated differently too."



Because e-cigarettes are fundamentally different from other tobacco products, they need to be treated differently too.

But because there aren't as many congressmen that vape, ecigs can be treated the same.

 

[HBcorpse]

HMMMMM...

Just as we see some tiny specks of light with some Big Letter Agencies walking their words back on vaping...we get stuff like this:

https://vaping.com/blog/news/vapers-sue-juul-for-nicotine-addiction/

Only in America.

That reminds me...I need to sue Coca~Cola for how delicious their products are...I’m addicted to sugar, thanks to them!

 

[zoiDman]

 

[stols001]

Well since tobacco lawsuits were outlawed but the juul has deep pockets, it's just the natural next progression I guess.

Doesn't the juul have one of those "danger, this product contains nicotine stickers yet?"

Anyway, I hate people and I try hard not to but then stuff such as THIS. There should be a parenting test before pregnancy, and an IQ and emotional intelligence test before lawsuit.

Also, WTH 15 year old not only gets away with ILLEGAL but gets to SUE over it?

God.

Anna

 

[Shawn Hoefer]

Can I sue Frito-Lays for making me fat?

Sent from my LG-H931 using Tapatalk

 

[stols001]

I kind of want to become a lawyer, but I would become the kind of lawyers who sued people for suing people over frivolous crap.

I bet there's a market! Only, law skool, bet it's nothing like the school of rock or Rock school academy or whatever,.

Anna

 

[Rossum]

HMMMMM...

Just as we see some tiny specks of light with some Big Letter Agencies walking their words back on vaping...we get stuff like this:

https://vaping.com/blog/news/vapers-sue-juul-for-nicotine-addiction/

Only in America.

That reminds me...I need to sue Coca~Cola for how delicious their products are...I’m addicted to sugar, thanks to them!

Two out of three of these suits were filed by people who were smokers. So the claim that Juul is what got them addicted to nicotine is a total farce.

 

[stols001]

I was going to ask where those suits were filed and then I was like, "Just read the entire article, I'm sure it's there."

CA. So, we're doomed I think they're all going to get damages.

I seriously ALSO think that CA needs to stay out of bankruptcy for at LEAST fifty years to be ALLOWED to participate in like, Federal matters or any NON internal matters to be frank. This has less to do with politics, per se, than a sort of, "You don't GET to have Federal input, period, until you learn to manage YOUR own affairs, sort of like how new drivers have to pass a driving test before they are allowed to drive, etc.

GAH.

Anna

 

[coldgin96]

Can I sue Frito-Lays for making me fat?

Sent from my LG-H931 using Tapatalk

Yes.

 

[Alexander Mundy]

Walnuts Are Drugs,... Says FDA

"The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?"

 

[zoiDman]

Yeah... Be careful what you say your Product can do.

Diamond Foods settles suit over walnut claims - Lexology

 

[Myk]

Walnuts Are Drugs,... Says FDA

"The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?"

They've done similar with cherries.

But this will be a fun article because there have been quacks pushing walnuts as a cure for incurable diseases on Twitter.

 

[stols001]

Okay I can understand directions to CRACK a walnut, but to actually eat them?

I think tart cherry supplement or something is supposed to do something like all supplements. I believe it was "reduce inflammation" perhaps or something similarly murky like all supplements. I am annoyed by supplements in general because 99% of them are worthless, but St. John's Wort actually works (as does melatonin) and they're just mixed in with the regular supplements the ones that do nothing, and if you happen upon St. John's Wort during the wrong moment of your life, like if you are also taking an SSRI or are susceptible to like serotonin levels like I am.

My free naturopath at my last job the first thing I told her, I mainly went there for b-12 shots which are like "rocket fuel" seriously, the first thing I told her was, "Don't give me St. John's wart whatever you do.

She gave me a shot but also some REALLY KNARLY looking tea, which I did not try. I brought it back and said, "I did not try this it somehow looked like something that would kill me what is in it?"

"St. John's wart," she replied. I told her she was an ijjit and poor listener pretty much, and then she said I had access to the "Deep, hidden wisdom of my inner intuitive body." And I said something to the effect of, "No, I don't think that's it, I just want my Vitamin B shot and also, please don't give me supplements that are unlabeled and opened ever again."

I eat a lot of cherries whenever I can obtain them, but only because I like the taste.

Anna

 

[zoiDman]

Someone sent me this Article as kinda an Overview of where things are with the FDA regarding e-Cigarettes...

https://www.thecontinuumofrisk.com/...ts-continuum-risk-update-deeming-rule-appeal/

It has some Informational Links in it which go into more Details. So I thought I would Pass it Along.

 

[untar]

Oral arguments in the Deeming Rule appeal have been scheduled for September 11

 

[Rossum]

Someone sent me this Article as kinda an Overview of where things are with the FDA regarding e-Cigarettes...

https://www.thecontinuumofrisk.com/...ts-continuum-risk-update-deeming-rule-appeal/

Gottlieb is quoted:

[w]e believe in the concept of a continuum of risk related to tobacco products, and we believe there is a role for modified risk products.

Really? Then how about approving some MRTPs? I know there are several that the FDA could approve if there were serious about this, and allowing the manufacturers to state that their products are less harmful would go a long way toward getting people to switch.

Further, we want to preserve e-cigs as one among a number of possible options for adult smokers and believe that fully transitioning smokers to ENDS can reduce the morbidity and mortality associated with tobacco use.”

I actually believe him when he says that. I mean I don't think it was Zeller who decided to delay the PMTA deadline for four years, or to not enforce the "No new products after 8/8/16" portion of the Deeming regs.

 

[zoiDman]

...

I actually believe him when he says that. I mean I don't think it was Zeller who decided to delay the PMTA deadline for four years, or to not enforce the "No new products after 8/8/16" portion of the Deeming regs.

I also Believe him.

The Question (to Me) has Always been in what Form will these "preserved" e-Cigarettes be? And what will an e-Liquid look like in a Fully FDA Regulated Market?

 

[untar]

I find the overall undertone of "product to quit smoking" slightly concerning in that regard. If it is regulated to be a tool solely for health purposes and no room is left for a non essential food item (in lack of a good translation of the German word "Genußmittel" ~ "indulgence agent")) then outlook on liquid choice and devices may be bleak (for non veterans).

 

[Myk]

Okay I can understand directions to CRACK a walnut, but to actually eat them?

I think tart cherry supplement or something is supposed to do something like all supplements. I believe it was "reduce inflammation" perhaps or something similarly murky like all supplements. I am annoyed by supplements in general because 99% of them are worthless, but St. John's Wort actually works (as does melatonin) and they're just mixed in with the regular supplements the ones that do nothing, and if you happen upon St. John's Wort during the wrong moment of your life, like if you are also taking an SSRI or are susceptible to like serotonin levels like I am.

My free naturopath at my last job the first thing I told her, I mainly went there for b-12 shots which are like "rocket fuel" seriously, the first thing I told her was, "Don't give me St. John's wart whatever you do.

She gave me a shot but also some REALLY KNARLY looking tea, which I did not try. I brought it back and said, "I did not try this it somehow looked like something that would kill me what is in it?"

"St. John's wart," she replied. I told her she was an ijjit and poor listener pretty much, and then she said I had access to the "Deep, hidden wisdom of my inner intuitive body." And I said something to the effect of, "No, I don't think that's it, I just want my Vitamin B shot and also, please don't give me supplements that are unlabeled and opened ever again."

I eat a lot of cherries whenever I can obtain them, but only because I like the taste.

Anna

I think we should be allowed to know cherries can reduce inflammation or walnuts contain omega-3 or ecigs can replace smoking without them being medical products.

Yet we can't find out actual medical products will kill you until there's a late night ambulance chaser ad on TV because the FDA was paid off to deem them as safe.